Live Webinar Personnel Training to Assure FDA and ISO Compliance

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar


May 31, 2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.
A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to verify training effectiveness, and how to document training so that it is readily available for review (by managers, auditors or inspectors).

Areas Covered

• •  Regulatory requirements for personnel training
• •  Establishment of a training program
• •  New employee training
• •  Methods of training
• •  Making training records “readily available for review”
• •  Evaluation of training requirements
• •  Verification of training effectiveness
• •  When is training not required?

Who will Benefit

• •  Training departments (if you’re lucky enough to have one)
• •  Personnel who perform training
• •  Personnel who receive training
• •  Low-mid level management
• •  Regulatory Affairs personnel
• •  Human resources (HR) staff

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

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